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A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy

Primary Purpose

Bowel Dysfunction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational video
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bowel Dysfunction focused on measuring Colonoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. At least 18 years of age
  2. Subjects who have the ability to give consent
  3. Subjects who are scheduled for colonoscopy as out patient
  4. Subjects consenting to participate in the study
  5. Subjects who are able to read and understand English

Exclusion Criteria:

  1. < 18 years age
  2. Subjects from whom consent cannot be obtained for any reason.
  3. Subjects who are scheduled for colonoscopy as in patient
  4. Subjects who are scheduled for colonoscopy within a time period or a situation where the educational material cannot be properly delivered to the study participant.
  5. Subjects who are advised to undergo bowel prep for more than one day.
  6. Subjects undergoing bowel prep with medications other than Colyte.
  7. Subjects who do not have access to equipment to watch the video (TV/CD player)
  8. Pregnant patients
  9. Prisoners
  10. Subjects who are not able to read or understand English.

(j)Subjects who had bowel resection surgery

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Instructions printed on a paper.

Paper and video instructions

Arm Description

There will be no intervention.

.Instructions printed on paper and a educational video.

Outcomes

Primary Outcome Measures

Quality of bowel preparation
Quality of bowel preparation at the time when the colonoscopy procedure is performed as reported by the physician performing the colonoscopy.

Secondary Outcome Measures

Adenoma detection rate
Number of patients undergoing screening colonoscopy for average risk in whom an adenoma was detected.

Full Information

First Posted
December 11, 2013
Last Updated
July 27, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02013505
Brief Title
A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy
Official Title
A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Study expired; Investigator left facility.
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators hypothesised that a video based patient education will help patients understand the process of colon cleansing prior to a colonoscopy procedure and hence will result in clean colons that will may help physician perform a better quality examination.
Detailed Description
After obtaining consent over phone, the investigators randomly assigned assigned participants to receive either the standard paper based instructions or receive an educational video in addition to the standard paper based instruction. Physicians performing the procedure were blinded to this assignment. The investigators obtained information relating to the cleanliness of the colon as noted during the colonoscopy examination. The investigators obtained this information from the colonoscopy reports. The investigators also obtained information regarding colon polyps,wanting to see if there is any difference in the number of patients in whom adenomatous polyps were detected. Outcome measures: Primary Out come: 1.Quality of bowel preparation Secondary outcome: Adenoma detection rate Rate of incomplete procedures due to poor bowel prep.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Dysfunction
Keywords
Colonoscopy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Instructions printed on a paper.
Arm Type
No Intervention
Arm Description
There will be no intervention.
Arm Title
Paper and video instructions
Arm Type
Experimental
Arm Description
.Instructions printed on paper and a educational video.
Intervention Type
Other
Intervention Name(s)
Educational video
Intervention Description
An educational video was developed based on the current paper instructions for bowel preparation. The video included a physician explaining the process, using more images and short clip videos of the example. The script of the video was approved by the patient education department of the University Hospital and language adjusted to 6th grade level.
Primary Outcome Measure Information:
Title
Quality of bowel preparation
Description
Quality of bowel preparation at the time when the colonoscopy procedure is performed as reported by the physician performing the colonoscopy.
Time Frame
At the time of colonoscopy
Secondary Outcome Measure Information:
Title
Adenoma detection rate
Description
Number of patients undergoing screening colonoscopy for average risk in whom an adenoma was detected.
Time Frame
At time of colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Subjects who have the ability to give consent Subjects who are scheduled for colonoscopy as out patient Subjects consenting to participate in the study Subjects who are able to read and understand English Exclusion Criteria: < 18 years age Subjects from whom consent cannot be obtained for any reason. Subjects who are scheduled for colonoscopy as in patient Subjects who are scheduled for colonoscopy within a time period or a situation where the educational material cannot be properly delivered to the study participant. Subjects who are advised to undergo bowel prep for more than one day. Subjects undergoing bowel prep with medications other than Colyte. Subjects who do not have access to equipment to watch the video (TV/CD player) Pregnant patients Prisoners Subjects who are not able to read or understand English. (j)Subjects who had bowel resection surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilip Bearelly, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy

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